A Phase III Study of SM-13496 in Patients With Bipolar I Depression.

Brief description of study

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients
with Bipolar I Depression.

Detailed Study Description

The primary objective is to compare the efficacy of SM-13496 (20-60 or 80-120 mg/day)
monotherapy with that of placebo in patients with depressive symptoms associated with
bipolar I disorder by assessing the change from baseline in the MADRS total score at Week 6.